ELITech Clinical Systems GLUCOSE PAP SL is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of glucose in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.

ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.

ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.

Device Description

ELITech Clinical Systems GLUCOSE PAP SL is available as kit only. It consists of 1 reagent, "R." Reagent R consists of Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase (Aspergillus sp.), Peroxidase (horseradish) and sodium azide.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

AI/ML Overview

The provided text describes three medical devices seeking 510(k) clearance: ELITech Clinical Systems GLUCOSE PAP SL reagent, ELITech Clinical Systems ELICAL 2 calibrator, and ELITech Clinical Systems ELITROL I and ELITROL II controls. The submissions focus on demonstrating substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study data presented for each device, structured according to your requested information:

1. ELITech Clinical Systems GLUCOSE PAP SL reagent

This device is a glucose reagent used for quantitative determination of glucose in human serum and plasma. The submission compares its performance to the ABX PENTRA GLUCOSE PAP CP predicate device.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	ELITech Clinical Systems GLUCOSE PAP SL (Reported Performance)	Predicate Device (ABX PENTRA GLUCOSE PAP CP)
Intended Use	Quantitative in vitro diagnostic determination of glucose in human serum and plasma. Not for Point of Care.	For quantitative in vitro diagnostic determination of glucose in human serum and plasma. Not for Point of Care.	For quantitative determination of glucose in serum and plasma.
Indication(s) for Use	Diagnosis and treatment of carbohydrate metabolism disorders.	Measures glucose for diagnosis and treatment of carbohydrate metabolism disorders (diabetes, hypoglycemia, pancreatic islet cell carcinoma).	Measures glucose for diagnosis and treatment of carbohydrate metabolism disorders (diabetes, hypoglycemia, pancreatic islet cell carcinoma).
Assay Protocol	Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method).	Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method).	Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method).
Composition	Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase, Peroxidase, Sodium azide.	Identical composition: Phosphate buffer (pH 7.4) 13.8 mmol/L, Phenol 10 mmol/L, 4-Aminoantipyrine 0.3 mmol/L, Glucose oxidase ≥ 10 000 U/L, Peroxidase ≥ 700 U/L, Sodium azide < 0.1%.	Identical composition.
Appearance of Reagent	Liquid form, ready to use.	Liquid form, ready to use.	Same.
Sample Type	Serum, Plasma.	Serum, Plasma.	Serum, Plasma.
Reagent Storage	Store at 2-8 °C, protected from light, stable until expiry.	Store at 2-8 °C, protected from light. Stable until expiry date.	Store at 2-8 °C, stable up to expiry date (unopened cassette).
Expected Values	Serum, plasma: 74 - 106 mg/dL.	Serum, plasma: 74 - 106 mg/dL.	Serum, plasma: 74 - 106 mg/dL.
Measuring Range	Comparable range, with rerun/post-dilution capabilities.	20.0 to 400.0 mg/dL (Rerun: 800.0 mg/dL).	1.8 to 432 mg/dL (Automatic post-dilution: 1296 mg/dL).
Detection Limit	Low detection limit.	0.5 mg/dL.	1.8 mg/dL.
Precision (Within Run CV)	Low coefficient of variation (CV).	Level 36.5 mg/dL: 1.6%Level 107.4 mg/dL: 1.4%Level 301.5 mg/dL: 1.0%	Level 89.36 mg/dL: 0.41%Level 230.53 mg/dL: 0.40%Level 42.76 mg/dL: 0.62%Level 111.47 mg/dL: 0.30%Level 296.22 mg/dL: 0.49%
Precision (Total CV)	Low coefficient of variation (CV).	Level 36.5 mg/dL: 2.9%Level 107.4 mg/dL: 2.5%Level 301.5 mg/dL: 2.1%	Level 90.20 mg/dL: 1.23%Level 235.44 mg/dL: 1.12%Level 107.18 mg/dL: 1.44%Level 298.97 mg/dL: 1.05%
Method Comparison	Strong correlation ($r^2$) and acceptable bias to predicate.	y = 0.953 x + 3.05 mg/dL$r^2$ = 0.997Range: 17.9 to 417.2 mg/dL.	y = 0.98 x + 0.72 mg/dL$r^2$ = 0.9974.
Limitations (Interference)	Identified interferences at certain concentrations.	Hemoglobin: POSITIVE bias from 250 mg/dL (low serum), no significant interference up to 500 mg/dL (medium serum).Triglycerides: POSITIVE bias from 814 mg/dL.Unconjugated bilirubin: POSITIVE bias from 15 mg/dL (low serum), NEGATIVE bias from 18 mg/dL (medium serum).Conjugated bilirubin: NEGATIVE bias from 8 mg/dL (low serum), from 18 mg/dL (medium serum).Ascorbic acid: NEGATIVE bias from 2 mg/dL (low serum), from 12 mg/dL (medium serum).Uric acid: NEGATIVE bias from 19 mg/dL (low serum), no significant interference up to 24 mg/dL (medium serum).Methyldopa: NEGATIVE bias from 0.9 mg/dL (low serum), no significant interference up to 1 mg/dL (medium serum).	Hemoglobin: No significant influence up to 460 mg/dL.Triglycerides: No significant influence up to 613 mg/dL.Total bilirubin: No significant influence up to 8.19 mg/dL.Direct bilirubin: No significant influence up to 5.63 mg/dL.
Calibration Frequency	Stable calibration period.	28 days.	11 days.
On-board Stability	Reagent stability when loaded on instrument.	28 days (refrigerated area).	83 days (refrigerated area).

2. Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The "Method comparison" section refers to a "range: 17.9 to 417.2 mg/dL" which implies a distribution of glucose concentrations were tested, but the number of individual samples is not provided. The data provenance is not mentioned (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a clinical chemistry assay, where the "ground truth" for comparison is typically another established, validated reference method (the predicate device in this case), not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of clinical chemistry assay comparison.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a standalone diagnostic reagent, not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The performance presented is for the device as a standalone reagent in conjunction with the specified analyzer. There is no human-in-the-loop component for interpretation in this context.
7. The type of ground truth used: The performance of the ELITech Clinical Systems GLUCOSE PAP SL was compared against the predicate device (ABX PENTRA GLUCOSE PAP CP) using patient samples, with the predicate device serving as the comparative "ground truth" for method comparison studies.
8. The sample size for the training set: Not applicable. This is a reagent for a clinical chemistry assay, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

2. ELITech Clinical Systems ELICAL 2 calibrator

This device is a multi-parametric calibrator. The submission compares its characteristics to the Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) predicate device.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	ELITech Clinical Systems ELICAL 2 (Reported Performance)	Predicate Device (Roche Calibrator f.a.s.)
Intended Use	Multi-parametric calibrator for in vitro diagnostic use in calibration of quantitative methods on specified analyzers.	Multi-parametric calibrator for in vitro diagnostic use in calibration of quantitative ELITech Clinical Systems methods on Vital Scientific Selectra Junior and Flexor Junior Analyzers.	For in vitro diagnostic use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers.
Format	Lyophilized calibrator based on human serum with added constituents.	Lyophilized calibrator based on human serum with constituents added to obtain desired levels.	Lyophilized calibrator based on human serum with constituents added to obtain desired levels.
Level	Single level.	Single level.	Single level.
Handling	Specific instructions for reconstitution.	Carefully open vial, pipette 3 mL distilled/deionized water, close, gently swirl to dissolve within 30 minutes, avoid foam.	Carefully open bottle, pipette 3 mL distilled/deionized water, close, gently swirl to dissolve within 30 minutes, avoid foam.
Traceability	Traceability information provided.	Traceability information given in the value sheet.	Traceability of the target value given in the instruction for use of system reagents.
Stability (Lyophilized)	Stable at 2-8°C until expiry.	At 2-8°C and protected from light until expiry date.	At 2-8°C up to expiration date.
Stability (Reconstituted)	Specific stability periods at various temperatures.	- 8 hours at 15-25 °C.- 2 days at 2-8 °C.- 4 weeks at -25 to -15 °C (when frozen once).	- 8 hours at 15-25 °C.- 2 days at 2-8 °C.- 4 weeks at -25 to -15 °C (when frozen once). (Exceptions for bilirubin noted).
Components	List of analytes (Glucose, Total Protein included in this submission).	Includes Glucose and Total Protein.	Assumed to include similar analytes for calibration. Not explicitly listed for the predicate here.

2. Sample size used for the test set and the data provenance: Not explicitly stated. For a calibrator, "test set" would typically refer to stability studies or studies confirming assigned values, but specific numbers and provenance are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Calibrator values are assigned based on reference methods and extensive testing, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The performance is for the calibrator as a component in a diagnostic system.
7. The type of ground truth used: The "ground truth" for a calibrator relates to its assigned values matching reference methods or being traceable to international standards. The submission states "Traceability information is given in the value sheet included in the box," implying this is how its "truth" is established.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

3. ELITech Clinical Systems ELITROL I and ELITROL II controls

These devices are two-level quality control products. The submission compares their characteristics to the Roche Diagnostics Precinorm U and Precipath U predicate devices.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	ELITech Clinical Systems ELITROL I / ELITROL II (Reported Performance)	Predicate Device (Roche Precinorm U / Precipath U)
Intended Use	Multi-parametric control serum for accuracy control of quantitative methods on specified analyzers.	Multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on Vital Scientific Selectra Junior and Flexor Junior Analyzers.	For in vitro diagnostic use in quality control by monitoring accuracy and precision for quantitative methods.
Format	Lyophilized human sera with added constituents.	Lyophilized human sera with constituents added to obtain desired levels.	Lyophilized human sera with constituents added to obtain desired levels.
Levels	Two levels.	Two levels.	Two levels.
Handling	Specific instructions for reconstitution.	Carefully open vial, pipette 5 mL distilled/deionized water, close, gently swirl to dissolve within 30 minutes, avoid foam.	Carefully open bottle, pipette 5 mL distilled/deionized water, close, gently swirl to dissolve within 30 minutes, avoid foam.
Stability (Lyophilized)	Stable at 2-8°C until expiry.	At 2-8°C and protected from light until expiry date.	At 2-8°C up to expiration date.
Stability (Reconstituted)	Specific stability periods at various temperatures.	- 12 hours at 15-25 °C.	- 12 hours at 15-25 °C.
Components	List of analytes (Glucose, Total Protein included in this submission).	Includes Glucose and Total Protein.	Assumed to include similar analytes for quality control. Not explicitly listed for the predicate here.

2. Sample size used for the test set and the data provenance: Not explicitly stated. For controls, "test set" would typically refer to stability studies or studies confirming assigned values and control ranges. Specific numbers and provenance are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Control values are assigned based on reference methods and extensive testing, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The performance is for the control materials as components in a diagnostic system.
7. The type of ground truth used: The "ground truth" for controls relates to their assigned values matching reference methods or being traceable to international standards, as well as their stability characteristics.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Overall Conclusion:

For all three devices, the "acceptance criteria" appear to be meeting or demonstrating comparability to the performance and characteristics of the respective predicate devices across various parameters (intended use, composition, analytical performance, stability, etc.). The studies performed are primarily analytical performance studies and comparisons, common for in vitro diagnostic devices seeking 510(k) clearance based on substantial equivalence. The document repeatedly concludes that "The performance data and other information demonstrate that the safety and effectiveness of this device [or these devices] versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device."

Summary

{0}------------------------------------------------

K/oos25

DEC 1 5 2010 SECTION 5 - 510(k) Summary ELITech Clinical Systems GLUCOSE PAP SL reagent According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. The assioned 510(k) number is: K100525 Submitter SEPPIM S.A.S. Zone Industrielle, 61500 SEES, FRANCE Address Phone number + 33 (0)2 33 81 21 00 Fax number + 33 (0)2 33 28 77 51 Contact Valérie GOURDON (Email: v.gourdon@elitechgroup.com) Monday, February 15th 2010 Date of Preparation Device names REAGENT : Trade/proprietary Name: ELITech Clinical Systems GLUCOSE PAP SL Common or Usual Name: Glucose, "GLUCOSE PAP SL" Device Class Class II Classification name Glucose test system (Sec.862.1345) Product code CGA - Glucose Oxidase, Glucose ABX PENTRA GLUCOSE PAP CP (K052007) Predicate device The device for this submission is available as kit only. It consists of 1 Device description reagent, "R." Reagent R consists of Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase (Aspergillus sp.), Peroxidase (horseradish) and sodium azide. ELITech Clinical Systems GLUCOSE PAP SL is intended for use with Intended Use ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELI-TROL I and ELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitative in vitro diagnostic determination of glucose in human serum and plasma. It is not intended for use in Point of Care settings. ELITech Clinical Systems GLUCOSE PAP SL is intended to measure Indication(s) for Use

glucose in human serum and plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma

{1}------------------------------------------------

Comparison to Predicate device

	ELITech Clinical Systems DeviceGLUCOSE PAP SL	Predicate device(ABX PENTRA GLUCOSE PAP CP)
Intended use	Intended for use with ELITechClinical Systems ELICAL 2 andELITech Clinical Systems ELI-TROL I and ELITROL II on VitalScientific Selectra/Flexor analyz-ers for the quantitative in vitrodiagnostic determination of glu-cose in human serum and plas-ma. It is not intended for use inPoint of Care settings.	For in vitro diagnostic use in thequantitative determination of glucosein serum and plasma.
Indication(s) for Use	Intended to measure glucose inhuman serum and plasma. Glu-cose measurements are used inthe diagnosis and treatment ofcarbohydrate metabolism disor-ders including diabetes mellitus,neonatal hypoglycemia, and idio-pathic hypoglycemia, and of pan-creatic islet cell carcinoma.	Intended to measure glucose in hu-man serum and plasma. Glucosemeasurements are used in the diag-nosis and treatment of carbohydratemetabolism disorders including dia-betes mellitus, neonatal hypoglyce-mia, and idiopathic hypoglycemia,and of pancreatic islet cell carci-noma.
Assay protocol	Enzymatic method using glucoseoxidase coupled with peroxidase(Trinder method).	Enzymatic method using glucoseoxidase coupled with peroxidase(Trinder method).
Composition	Reagent R:Phosphate buffer; pH 7.4 13.8 mmol/L ;Phenol 10 mmol/L ;4-Aminoantipyrine 0.3 mmol/L :Glucose oxidase ≥ 10 000 U/L :Peroxidase ≥ 700 U/L ;Sodium azide < 0.1%;	Reagent :Phosphate buffer; pH 7.4 13.8 mmol/L ;Phenol 10 mmol/L ;4-Aminoantipyrine 0.3 mmol/L ;Glucose oxidase ≥ 10 000 U/L ;Peroxidase ≥ 700 U/L ;Sodium azide < 0.1%;
Appearance of reagent	Liquid form, ready to use	Same
Sample type	SerumPlasma	SerumPlasma
Reagent storage	Store at 2-8 °C and protected fromlight. The reagent is stable until theexpiry date stated on the label.	Reagents, in unopened cassette, arestable up to expiry date on the label ifstored at 2-8 °C.
Expected values	Serum, plasma74 - 106 mg/dL	Serum, plasma74 - 106 mg/dL
Instrument	SELECTRA JUNIOR	ABX PENTRA 400
Measuring range	20.0 to 400.0 mg/dLRerun: 800.0 mg/dL	1.8 to 432 mg/dLAutomatic post-dilution: 1296 mg/dL
Detection	0.5 mg/dL	1.8 mg/dL
Precision	Within runLevel 36.5 mg/dL CV=1.6%Level 107.4 mg/dL CV=1.4%Level 301.5 mg/dL CV=1.0%	Within runLevel 89.36 mg/dL CV=0.41%Level 230.53 mg/dL CV=0.40%Level 42.76 mg/dL CV=0.62%Level 111.47 mg/dL CV=0.30%Level 296.22 mg/dL CV=0.49%
	ELITech Clinical Systems DeviceGLUCOSE PAP SL	Predicate device(ABX PENTRA GLUCOSE PAP CP)
	Total	Total
	Level 36.5 mg/dL CV=2.9%	Level 90.20 mg/dL CV=1.23%
	Level 107.4 mg/dL CV=2.5%	Level 235.44 mg/dL CV=1.12%
	Level 301.5 mg/dL CV=2.1%	Level 107.18 mg/dL CV=1.44%
		Level 298.97 mg/dL CV=1.05%
Method comparison	y=0.953 x + 3.05 mg/dL$r^2$ = 0.997range: 17.9 to 417.2 mg/dL	y= 0.98 x + 0.72 mg/dL$r^2$ = 0.9974
Limitations	Hemoglobin: Positive bias from 250 mg/dL on low human serum.No significant interference up to 500 mg/dL on medium human serum.Triglycerides: Positive bias from 814 mg/dL.Unconjugated bilirubin: Positive bias from 15 mg/dL on low human serum. Negative bias from 18 mg/dL on medium human serum.Conjugated bilirubin: Negative bias from 8 mg/dL on low human serum and from 18 mg/dL on medium human serum.Ascorbic acid: Negative bias from 2 mg/dL on low human serum and from 12 mg/dL on medium human serum.Uric acid: Negative bias from 19 mg/dL on low human serum. No significant interference up to 24 mg/dL on medium human serum.Methyldopa: Negative bias from 0.9 mg/dL on low human serum. No significant interference up to 1 mg/dL on medium human serum.	Hemoglobin: No significant influence is observed up to 460 mg/dL.Triglycerides: No significant influence is observed up to 613 mg/dL.Total bilirubin: No significant influence is observed up to 8.19 mg/dL.Direct bilirubin: No significant influence is observed up to 5.63 mg/dL.
Calibration Frequency	28 days	11 days
On board stability	refrigerated area : 28 days	refrigerated area: 83 days
Calibrator	Recommended calibration material (not included):ELITech Clinical Systems Elical 2	Recommended calibration material (not included):ABX Pentra Multical
Controls	Recommended quality control material (not included):ELITech Clinical Systems Elitrol I (Normal control)ELITech Clinical Systems Elitrol II (Pathologic control)	Recommended quality control material (not included):ABX Pentra N Control (Normal control)ABX Pentra P Control (Pathologic control)

{2}------------------------------------------------

Conclusion

The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its predicate device.

{3}------------------------------------------------

SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELICAL 2

Introduction	According to the requirements of 21 CFR 807.92, the followinginformation provides sufficient detail to understand the basis for a de-termination of substantial equivalence.
	The assigned 510(k) number is: K100525
Submitter	SEPPIM S.A.S.
Address	Zone Industrielle, 61500 SEES, FRANCE
Phone number	+ 33 (0)2 33 81 21 00
Fax number	+ 33 (0)2 33 28 77 51
Contact	Valérie GOURDON (Email: v.gourdon@elitechgroup.com)
Date of Preparation	Monday, February 15th 2010
Device names
REAGENT :	ELITech Clinical Systems ELICAL 2
Trade/proprietary Name:	ELITech Clinical Systems ELICAL 2
Common or Usual Name:	Calibrator, multi-analyte mixture, "ELICAL 2"
Device Class	Class II
Classification name	Calibrator (21 CFR 862.1150)
Product code	JIX- Calibrator, multi-analyte mixture
Predicate device	Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)(K033501)
Device description	ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based onhuman serum containing constituents to ensure optimal calibration.ELICAL 2 is prepared exclusively from the blood of donors tested individuallyand found to be negative for HbsAg and to antibodies to HCV and HIV ac-cording to FDA-approved methods or methods in compliance with the Euro--pean Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Sys-tems methods on the Vital Scientific Selectra Junior Analyzer and the VitalScientific Flexor Junior Analyzer.

{4}------------------------------------------------

Comparison to Predicate device

	ELITech Clinical Systems Device(ELICAL 2)	Predicate device(Roche Calibrator f.a.s.)
Intended use	ELITech Clinical Systems ELICAL2 is a multi-parametric calibratorfor in vitro diagnostic use in thecalibration of quantitative ELITechClinical Systems methods on theVital Scientific Selectra JuniorAnalyzer and the Vital ScientificFlexor Junior Analyzer.	For in vitro diagnostic use in thecalibration of quantitative Rochemethods on Roche clinical chemis-try analysers as specified in thevalue sheets.
Format	Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels	Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels
Level	Single level	Single level
Handling	Carefully open the vial, avoiding theloss of lyophilate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam.	Carefully open one bottle, avoidingthe loss of lyophilate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation offoam.
Traceability	Traceability information is given inthe value sheet included in the box.	Traceability of the target value isgiven in the respective instructionfor use of the system reagents.
Stability	Lyophilized:To store at 2-8°C and protectedfrom light until the expiry dateAfter reconstitution, the stabilitiesare :- 8 hours between 15-25 °C.- 2 days between 2-8 °C.- 4 weeks between -25 and -15 °C(when frozen once)	Lyophilized:Stable at 2-8°C up to expirationdate.After reconstitution, the stabilitiesare :- 8 hours at 15-25 °C.- 2 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once)Exception for bilirubin total & directas noted in package insert

Elical 2 assigned values are the following ones:

Components	Under review	Included in thissubmission	Cleared
AST-GOT			K093883
Glucose		X
Phosphorus	K100263
Total Protein		X
Urea	K100263
BUN	K100263

{5}------------------------------------------------

A-L-A-A-A-A-A-A-A-Uric acıd	K100263
Cholesteroi	1K102993	A PROPER OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTIComments of Concession of Children of	Sheep States of Corporary of Career of Carrier of Children Company of Children Company of
TriglyceridesA 80 000 000	K102993

Conclusion The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.

{6}------------------------------------------------

SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELITROL I and ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Introduction	According to the requirements of 21 CFR 807.92, the followinginformation provides sufficient detail to understand the basis for a de-termination of substantial equivalence.
	The assigned 510(k) number is: K100525
Submitter	SEPPIM S.A.S.
Address	Zone Industrielle, 61500 SEES, FRANCE
Phone number	+ 33 (0)2 33 81 21 00
Fax number	+ 33 (0)2 33 28 77 51
Contact	Valérie GOURDON (Email: v.gourdon@elitechgroup.com)
Date of Preparation	Monday, February 15th 2010
Device names
CONTROLS:Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code	ELITech Clinical Systems ELITROL I and ELITROL IIMulti-analyte controls - all kinds, "ELITROL I"- "ELITROL II"Class IQuality control material (assayed and unassayed). (21 CFR862.1660)JJX- Multi-analyte controls - all kinds
Predicate device	Roche Diagnostics Precinorm U (K041227)Roche Diagnostics Precipath U (K041227)
Device description	ELITech Clinical Systems ELITROL I and ELITROL II are two level qualitycontrol products consisting of lyophilized human serum containing constituentsat desired levels.Elitrol I and Elitrol II are prepared exclusively from the blood of donors testedindividually and found to be negative for HbsAg and to antibodies to HCV andHIV according to FDA-approved methods or methods in compliance with theEuropean Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELITROL I is a multi-parametric control serum for invitro diagnostic use in accuracy control of quantitative ELITech Clinical Sys-tems methods on the Vital Scientific Selectra Junior Analyzer and the VitalScientific Flexor Junior Analyzer.ELITech Clinical Systems ELITROL II is a multi-parametric control serum for invitro diagnostic use in accuracy control of quantitative ELITech Clinical Sys-tems methods on the Vital Scientific Selectra Junior Analyzer and the VitalScientific Flexor Junior Analyzer.

{7}------------------------------------------------

Comparison to Predicate device

	ELITech Clinical Systems DeviceELITROL I / ELITROL II	Predicate DeviceRoche Precinorm U / Precipath U
Intended use	ELITech Clinical Systems ELITROLI is a multi-parametric control serumfor in vitro diagnostic use in accu-racy control of quantitative ELITechClinical Systems methods on theVital Scientific Selectra Junior Ana-lyzer and the Vital Scientific FlexorJunior Analyzer.ELITech Clinical Systems ELITROLII is a multi-parametric control se-rum for in vitro diagnostic use inaccuracy control of quantitativeELITech Clinical Systems methodson the Vital Scientific Selectra Jun-ior Analyzer and the Vital ScientificFlexor Junior Analyzer.	For in vitro diagnostic use in qualitycontrol by monitoring accuracy andprecision for the quantitative meth-ods as specified in the value sheet
Format	Lyophilized human sera with con-stituents added as required to ob-tain desired components levels	Lyophilized human sera with con-stituents added as required to ob-tain desired components levels
Levels	Two levels	Two levels
Handling	Carefully open the vial, avoiding theloss of lyophilate, and pipette inexactly 5 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam.	Carefully open the bottle, avoidingthe loss of lyophilate, and pipette inexactly 5 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation offoam.
Stability	Lyophilized:To store at 2-8°C and protectedfrom light until the expiry dateAfter reconstitution, the stabilitiesare :- 12 hours between 15-25 °C.	Lyophilized:Stable at 2-8°C up to expirationdate.After reconstitution, the stabilities*are :- 12 hours at 15-25 °C.

Elitrol I & Elitrol II assigned values are the following ones:

Components	Under review	Included in thissubmission	Cleared
AST-GOT			K093883
Glucose		X
Phosphorus	K100263

{8}------------------------------------------------

Total Protein		X
Urea	K100263
BUN	K100263
Uric acid	K100263
Cholesterol	K102993
Triglycerides	K102993

Conclusion

The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.

{9}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, symbolizing the department's mission related to health and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Seppim S.A.S. c/o Debra K. Hutson ELITechGroup Epoch Biosciences 21720 2310 Dr. SE, Suite 150 Bothell, Washington 98021

DEC 1 5 20:0

Re: K100525 Trade Name: ELITech Clinical Systems Glucose PAP SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL 1 and ELITROL 2 Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, JIX, JJX Dated: December 13, 2010 Received: December 15, 2010

Dear Ms. Hutson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{10}------------------------------------------------

Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courthey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{11}------------------------------------------------

Indications for Use Form

510(k) Number (if known): _K100525

Device Name:

Indications for Use:

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k/00.25

Page 1 of 3

{12}------------------------------------------------

Indications for Use Form

510(k) Number (if known): _K100525 ___________________________________________________________________________________________________________________________________________

DEC 1 5 2010

Device Name: ELITech Clinical Systems ELICAL 2______________________________________________________________________________________________________________

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ans 25

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k/00(-2)

Page Dof 3

{13}------------------------------------------------

Indications for Use Form

DEC 1 5 2010

510(k) Number (if known): K100525

Device Name: ELITech Clinical Systems ELITROL 1 and ELITROL 2

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K100524

Page of 3

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.